{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T18:50:34Z","timestamp":1791399034468,"version":"4.3.3"},"reference-count":30,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"10","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2016,4,1]]},"abstract":"Purpose<\/jats:title>Blinatumomab is a CD19\/CD3 BiTE (bispecific T-cell engager) antibody construct for the treatment of Philadelphia chromosome\u2013negative acute B-lymphoblastic leukemia. We evaluated blinatumomab in relapsed\/refractory B-cell non-Hodgkin lymphoma (NHL).<\/jats:p><\/jats:sec>Patients and Methods<\/jats:title>This 3 + 3 design, phase I dose-escalation study determined adverse events and the maximum tolerated dose (MTD) of continuous intravenous infusion blinatumomab in patients with relapsed\/refractory NHL. Blinatumomab was administered over 4 or 8 weeks at seven different dose levels (0.5 to 90 \u03bcg\/m2<\/jats:sup>\/day). End points were incidence of adverse events, pharmacokinetics, pharmacodynamics, and overall response rate.<\/jats:p><\/jats:sec>Results<\/jats:title>Between 2004 and 2011, 76 heavily pretreated patients with relapsed\/refractory NHL, who included 14 with diffuse large B-cell lymphoma, were enrolled; 42 received treatment in the formal dose-escalation phase. Neurologic events were dose limiting, and 60 \u03bcg\/m2<\/jats:sup>\/day was established as the MTD. Thirty-four additional patients were recruited to evaluate antilymphoma activity and strategies for mitigating neurologic events at a prespecified MTD. Stepwise dosing (5 to 60 \u03bcg\/m2<\/jats:sup>\/day) plus pentosan polysulfate SP54 (n = 3) resulted in no treatment discontinuations; single-step (n = 5) and double-step (n = 24) dosing entailed two and seven treatment discontinuations due to neurologic events, respectively. Grade 3 neurologic events occurred in 22% of patients (no grade 4\/5). Among patients treated at 60 \u03bcg\/m2<\/jats:sup>\/day (target dose; n = 35), the overall response rate was 69% across NHL subtypes and 55% for diffuse large B-cell lymphoma (n = 11); median response duration was 404 days (95% CI, 207 to 1,129 days).<\/jats:p><\/jats:sec>Conclusion<\/jats:title>In this phase I study of relapsed\/refractory NHL, continuous infusion with CD19-targeted immunotherapy blinatumomab at various doses and schedules was feasible, with an MTD of 60 \u03bcg\/m2<\/jats:sup>\/day. Single-agent blinatumomab showed antilymphoma activity.<\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2014.59.1586","type":"journal-article","created":{"date-parts":[[2016,2,17]],"date-time":"2016-02-17T04:28:53Z","timestamp":1455683333000},"page":"1104-1111","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":411,"title":["Bispecific T-Cell Engager (BiTE) Antibody Construct Blinatumomab for the Treatment of Patients With Relapsed\/Refractory Non-Hodgkin Lymphoma: Final Results From a Phase I Study"],"prefix":"10.1200","volume":"34","author":[{"given":"Maria-Elisabeth","family":"Goebeler","sequence":"first","affiliation":[{"name":"Maria-Elisabeth Goebeler, Stefan Knop, Max S. Topp, Hermann Einsele, and Ralf C. Bargou, Comprehensive Cancer Center Mainfranken, University of W\u00fcrzburg, W\u00fcrzburg; Andreas Viardot, University Ulm; Peter Kufer, Gerhard Zugmaier, Matthias Klinger, Andreas Wolf, Margit Schmidt, and Patrick A. Baeuerle, Amgen Research (Munich); Brigitte Dorsch, Metronomia Clinical Research, Munich; Richard Noppeney, University of Essen Medical Center, Essen; Georg Hess, Johannes Gutenberg-University, Mainz; Stefan Kallert..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"Knop","sequence":"additional","affiliation":[{"name":"Maria-Elisabeth Goebeler, Stefan Knop, Max S. Topp, Hermann Einsele, and Ralf C. Bargou, Comprehensive Cancer Center Mainfranken, University of W\u00fcrzburg, W\u00fcrzburg; Andreas Viardot, University Ulm; Peter Kufer, Gerhard Zugmaier, Matthias Klinger, Andreas Wolf, Margit Schmidt, and Patrick A. 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Baeuerle, Amgen Research (Munich); Brigitte Dorsch, Metronomia Clinical Research, Munich; Richard Noppeney, University of Essen Medical Center, Essen; Georg Hess, Johannes Gutenberg-University, Mainz; Stefan Kallert..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Kufer","sequence":"additional","affiliation":[{"name":"Maria-Elisabeth Goebeler, Stefan Knop, Max S. Topp, Hermann Einsele, and Ralf C. Bargou, Comprehensive Cancer Center Mainfranken, University of W\u00fcrzburg, W\u00fcrzburg; Andreas Viardot, University Ulm; Peter Kufer, Gerhard Zugmaier, Matthias Klinger, Andreas Wolf, Margit Schmidt, and Patrick A. 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